Source : 'Scrip Intelligence'
SK Bioscience has received an IND approval from South Korea's Ministry of Food and Drug Safety (MFDS) to begin a Phase I clinical trial with its COVID-19 vaccine candidate NBP2001.
The company, which conducted preclinical work on the synthetic antigen vaccine with the Korea Biotechnology Research Institute, says it has achieved neutralizing antibody concentrations about 10 times higher than in the plasma of people who have fully recovered from COVID-19, and has confirmed the antibodies blocked proliferation of the virus in the respiratory system.
Based on the promising results, the company plans to speed up the Phase I trial and gear up for additional clinical studies. SK said its aim was to develop a candidate with thoroughly verified safety and efficacy, even if the timeline is extended, but added it was expecting robust safety in the initial trial, which will take place at Seoul National University Hospital and Seoul National University Bundang Hospital.
Aside from NBP2001, the company is also developing another COVID-19 vaccine candidate, GBP510, now at the preclinical stages, with the support from Bill & Melinda Gates Foundation; it aims to take this into a clinical program this year.
Biological E Limited. has begun Phase I/II human trials in India for a COVID-19 vaccine developed in association with US-based Baylor College of Medicine and Dynavax Technologies Corporation. BCM Ventures has supplied the antigen and Dynavax its adjuvant CpG 1018. ()
The trial will evaluate the safety and immunogenicity of the vaccine candidate, consisting of the receptor binding domain of the spike protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in 360 participants aged 18 to 65 years.
The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart. Results from this trial are expected by January or February 2021, with Phase III trials to begin soon after in nearly 30,000 subjects and licensure expected by summer.
It is the fifth vaccine candidate to move into human trials in India after partnered or indigenous developed ones at Serum Institute of India Pvt. Ltd., Bharat Biotech, Zydus Cadila and Dr. Reddy's Laboratories Ltd.
South Korea's Dong Wha Pharmaceutical Ind. Co. has received an IND approval from the MFDS to begin a domestic Phase II clinical trial with its COVID-19 drug candidate, DW2008S.
The natural product-derived drug, an extract of the water willow plant, is said to inhibit allergic inflammation and bronchoconstriction and is already undergoing a Phase II study for the treatment of asthma. In COVID-19, the plan is to assess it for the treatment of patients with moderate disease.
In preclinical studies, the drug showed good improvement in lung function and sputum discharge, the company saying it had "excellent" tolerability and desirable pharmacokinetics confirmed in Phase I studies.
Celltrion, Inc. has completed administration of its COVID-19 antibody therapeutic candidate CT-P59 (regdanvimab) to 327 patients in a global Phase II trial. It plans to file for a conditional approval of the drug to South Korea's Ministry of Food and Drug Safety after confirming interim results.
The company has been progressing the study at sites in countries including South Korea, US, Romania and Spain, evaluating efficacy and safety in patients with mild-to-moderate disease, in low and high dose and placebo groups.
Celltrion has completed manufacturing of an initial batch of CT-P59, which acts on the virus spike protein receptor binding domain, sufficient to treat 100,000 patients in South Korea at its Songdo manufacturing facilities in the country, so that the drug can immediately be used for treatment once it receives conditional approval.
The company notes it is also set to begin soon an international Phase III trial in 10 countries to confirm efficacy and safety on a larger scale.
It is planning to manufacture quantities for a maximum of 1.5 million to 2 million patients annually, in a way that does not disrupt inventory levels and the global supplies of its other existing products.
By Scrip Team